Bianca Florina Selejean

Company Overview: HCLTech is a global technology company, across 60 countries, delivering industry-leading capabilities

Responsibilities:

• involved in transfer of old PFMEA documentation done conformed to ISO 14971 into new PFMCA documents according to latest ISO 14971/2019 International Standard for Medical Device Risk Management
• align with company Credo
• review old PFMEA documentation
• process visits along with project teams for an accurate Process Flow Mapping to assess potential hazards
• identify and assess product-related hazards and hazardous situations along with project teams
• provide evidence that processes are engineered to be Inherently Safe
• migrating old documents in new PFMCA template
• evaluating the probability of a hazardous situation occurring and how frequently patients or end-users are exposed to a hazard based on established controls and external/internal data sources
• review all process related documents
• led cross-functional teams to achieve project goals

Company Overview: Adient Jimbolia manufactures the metallic structure of passenger cars. Tier 2 supplier in automotive industry

Quality assurance for welding process, Customer claim management (VW project):

• daily meetings with process team members
• involved in continuous improvement programs
• maintaining COPQ within company targets
• provides data for PPAP and annual re-qualification of welding process
• optimised manufacturing processes through the application of Lean Six Sigma principles.
• responsible for creating and maintaining Control Plan documentation
• responsible for 5 Quality Technicians and their daily activities
• responsible for creating or/and updating Quality Work Instructions
• conducted training sessions to improve team's understanding of quality assurance protocols
• ensured compliance with industry standards using auditing techniques
• reviewed technical specifications to ensure adherence to quality standards
• implemented corrective actions to reduce manufacturing defect
• initiated effective communication channels for seamless information flow between departments
• responsible for customer claims (tier 1, Lear, Magna, Sitech)
• champion for 8D analysis
• access in customer portals
• improved product quality by completing company, system and compliance audits
• prioritized conflicting requirements, meeting tight deadlines and keeping projects on-task
• collaborated with engineering team to communicate and achieve quality standards and outputs
• created and issued Standard Operating Procedures for team members to follow
• updated relevant documentation, checking for accuracy and relevance

• Responsible for washing and closing system purchased components
• incoming process: define inspection criteria and handling the list of components to be inspected at incoming inspection
• supplier claim management: 8D creation for validated components, analysis and action plan follow up from supplier
• part in Project Management teams for new project introduction
• regular meetings with suppliers and project teams
• project reviews
• PPAP files approval of components from supplier
• define level of product and supplier risk together with Project Quality Engineer
• follow-up improvement programs with top worst suppliers
• KPI reporting:
• - supplier PPM
• - supplier 8D reactivity
• - SQE reporting follow up
• improved supplier quality performance by implementing rigorous audit processes
• fostered strong relationships with suppliers for improved communication and collaboration
• led cross-functional teams, ensuring superior product quality
• evaluated new suppliers to ensure compliance with company standards
• facilitated regular review meetings with suppliers, promoting open dialogue and continuous improvement

• Conceiving and sending claims to supplier, through SRM Portal
• Request and validate the QR from supplier
• Cost recovery through Credit Note, Debit Note
• Actions for stock isolation and sorting through external sorting companies coordination
• Monitoring of 'Supplier' quarantine area, quantity and value
• Participate at daily meetings regarding analysis and monitoring of open incidents
• Working with SAP system for transferring all defective parts
• Ask suppliers for YIS (Yearly Initial Sample), through SRM Portal and responsible for validation
• Carried out day-to-day duties accurately and efficiently

• Perform Quality tests in laboratory according specifications (control plan and customer requirements)
• Daily dimensional measurements by running 3D programs created according drawing requirements
• Climatic tests (climatic chamber Votsch) - climatic chamber programming and operating at different temperatures and humidity according customer request
• Electrical tests - programmable power supply programming and operating, electrical connections specific to every product
• Chemical tests
• Tightness, leakage tests
• Photometry tests according European and USA regulations in automotive industry
• Preparing and archiving of test reports
• Creating Work Instructions for new product tests
• Developing new tests programs according customer requirements
• Conducted routine calibration checks to ensure precision instrument performance
• Liaised effectively with other departments, facilitating better workflow management

Main Responsibilities:

• Incoming Quality Receiving Coordinator
• raises claims to supplier for quality problems of purchased products (most are foreign suppliers and conversation is in English)
• 8D actions follow-up
• recovery costs from suppliers related to quality issues of their components
• weekly reporting of main quality issues
• responsible for containment actions implementation (sort of stock) in Medias facility for supplier related quality issues
• coordinating incoming quality technician
• following status of products requiring quality inspection

Main responsibilities:

• attend the daily meetings on the production line for defect reporting and analysis
• attend the quality meetings for reporting the faults from the production line and status of the corrective actions defined
• block and keep the evidence of the defect parts from quarantine area
• check the conformity of the documentation on the line
• 100% control of finished goods, according to a checklist where are specified all points to be checked
• conducted routine calibration checks to ensure precision instrument performance
• liaised effectively with other departments, facilitating better workflow management
• monitored manufacturing processes closely, catching errors before mass production commenced
• facilitated day-to-day quality inspections and maintained related documentation
• wrote and modified WI's for use within QC and validation activities
• audited components and materials across all stages of manufacturing process
• gathered and maintained inspection records in company databases
• provided technical support to production teams, guiding processes to maintain quality adherence
• investigated quality issues to identify root causes and raise appropriate corrective action

Responsibilities:

• validate the product and process with specific measurements (dimensional and statistic control)
• responsible for process running and machines during the entire shift
• shift start up validation according specifications
• measurements according documentation to follow up the quality of the production during shifts
• quality decisions based on Customer requirements
• using of the measurement tools such as caliper, micrometer, torque wrench, feeler gage
• test and prototype measurement according new specifications
• completing and recording of the measurements reports
• scrap evaluation and mitigation
• utilized statistical analysis techniques to detect patterns and trends in data thereby improving process predictability and stability over time
• achieved consistent results by following strict quality protocols
• monitored manufacturing processes closely, catching errors before mass production commenced
• played a crucial role in obtaining ISO certification for the company through meticulous documentation and audit preparation
• carry out product tests and final inspection of finished assemblies

Pereno is a sub-group of Plastor company. Pereno company specializes in the production of ski bindings for renowned external partners active in the production of sports goods. The company uses state-of-the-art technological lines that can ensure the production of complex products, respecting the high quality requirements of customers

• responsible for the quality of the finished sub-assembled products (Salomon ski bindings).
• responsible for verifying shift production according documentation
• responsible for creating Control reports with the Quality decision after inspection
• documented non-conformities accurately for proper follow-up actions
• identified and resolved issues, ensuring continuous improvement in operations

Plastor is one of the biggest plastic manufacturer in west side of Romania.

Manufacture plastic components for automotive and industrial customers as well as winter sport equipment.

Activity: Mold-Injection, Blow-Molding, Finished products assembling, Molds.

Main responsibility:

• Production operator on mold injection machine
• Met tight deadlines through fast-paced work whilst maintaining attention to detail
• Maintained safe work environment by following safety procedures
• Participated in team meetings contributing ideas for continuous improvement initiatives
• Facilitated smooth workflow by organising materials for production line
• Contributed to team efforts, leading to improved overall production rates
• Reduced waste and increased efficiency by maintaining equipment in good working order
• Kept workspace clean and organized, ensuring a productive work environment

Diamant was one of the biggest sugar factory in Romania.

• Worked as a Production Operator in different stages of sugar processing
• Followed standard operating procedures, ensuring compliance and consistency in product quality
• Handled finished products for packaging and dispatch, streamlining the end-of-line process
• Participated in team meetings contributing ideas for continuous improvement initiatives
• Operated machinery following strict guidelines to ensure safety and quality control measures were met
• Kept workspace clean and organized, ensuring a productive work environment
• Reduced waste and increased efficiency by maintaining equipment in good working order
• Conducted maintenance checks on machinery, preventing unexpected breakdowns